Concurrent carboplatin, etoposide and thoracic radiation for poor-risk stage III non-small-cell lung carcinoma: A pilot study

Purpose: A pilot study was conducted to assess the tolerance and efficacy of concurrent carboplatin, etoposide, and thoracic radiation in poor-risk patients with Stage III non-small-cell lung carcinoma (NSCLC). Methods and Materials: Patients had Stages IIIA/IIIB NSCLC and were ineligible for available clinical trials employing cisplatin-based chemoradiation due to one or more protocol-defined poor-risk factors or concomitant medical conditions. Treatment consisted of thoracic radiation, 1.8 to 2 Gy daily, to the primary tumor and regional lymph nodes to a total dose of 61 Gy. Concurrently, patients received carboplatin 200 mg/m²/day intravenously on days 1, 3, 29, and 31, and etoposide 50 mg/m²/day intravenously on days 1-4 and 29-32. Response was assessed by chest computed tomography (CT) 4 weeks after treatment was completed. Results: A total of 26 patients were enrolled and 23 of these patients, including 11 with Stage IIIA and 12 Stage IIIB NSCLC, were eligible and assessable. Ninety-six percent (96%) of the patients completed the two planned courses of chemotherapy, and 87% completed the planned chest radiation. Grade III/IV toxicities included neutropenia in nine patients (39%), thrombocytopenia in five (22%), esophagitis in seven (30%), and nausea in two (9%). One patient died of a pulmonary embolism during treatment, and another died of complications due to a tracheoesophageal fistula. Four patients (17%) achieved a complete response and 16 (70%) a partial response, yielding an overall response rate of 87%. The median survival was 12 months, and the 2-year actuarial survival was 40%. Conclusion: This treatment regimen was well tolerated, with promising response and survival in poor-risk patients with Stage III NSCLC. These results are being validated in a Phase II trial conducted by the Southwest Oncology Group.